HDI oligomers, oxadiazintrione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HDI oligomers, oxadiazintrione

IUPAC Name:

HDI oligomers, oxadiazintrione

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: HC:NZW
- Source: Interfauna UK Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2.9, 3.1, and 3.1 kg
- Housing: singly in wire mesh cages (Typ III) on low dust wood granulate bedding
- Diet and water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral untreated eye was used as negative control

Amount / concentration applied:

100 µL

Duration of treatment / exposure:

The eyelids were gently held together for approx. one second before releasing.

Observation period (in vivo):

Examinations were terminated after 7 days, since all changes had completely subsided then.

Number of animals or in vitro replicates:

3

Details on study design:

100 µL of the test substance were instilled into the conjunctival sac of the eye and the lids were gently held together for approx. one second before releasing. 24 hours after the treatment the eye was rinsed with saline solution.
Readings were after 1, 24, 48, and 72 hours and after 7, 14, and 21 days.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein and UV-light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

3

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

>= 0 - <= 2

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: mean score: 0.7

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Applicant's summary and conclusion

Executive summary:

The potential of damage to the eye was investigated according to OECD TG 405 in three rabbits. In this study 100 µL of the test substance was instilled into the conjunctival sac of one eye, and the eye-lid was gently held together for approx. one second before releasing. The contralateral untreated eye of the animal served as negative control. Readings were according to Draize after 1, 24, 48, and 72 hours and after 7 days. Since all changes were subsided by then, the study was terminated.

The substance led to no findings for iris, cornea, chemosis and to a slight effect after 24 hours solely in one rabbit (mean score iris, cornea, chemosis 0; mean score conjunctiva redness 0.2). Complete reversibility was shown after 48 hours.